MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

K012459 · Medtronic Vascular · LDF · Aug 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012459
• Device Name: MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
• Applicant: Medtronic Vascular
• Product Code: LDF · Cardiovascular
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The device is supplied sterile and intended for single use only.

Device Story

Model 6494 Unipolar Temporary Myocardial Pacing Wire; insulated multi-filament wire with stripped electrode surface; distal atraumatic myocardial curved needle; proximal atraumatic chest needle for exit through chest wall. Used for temporary atrial/ventricular pacing and sensing; duration 7 days or less. Operated by clinicians in clinical settings. Device provides electrical connection between heart and external pacemaker; removed via gentle traction; no residual material remains in body. Single-use; sterile.

Clinical Evidence

Bench testing only. System compatibility testing performed including environmental conditioning, visual verification, dimensional testing, electrical testing, and mechanical testing. No clinical data presented.

Technological Characteristics

Insulated multi-filament wire; distal myocardial needle; proximal chest needle. Sterilized via 100% Ethylene Oxide (EtO). Packaging: Tyvek-polyester/polyethylene laminate pouches.

Indications for Use

Indicated for temporary atrial and ventricular pacing and sensing in patients requiring temporary cardiac pacing for a duration of 7 days or less.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• Model 6494 Unipolar Temporary Myocardial Pacing Wire (K012459)

Submission Summary (Full Text)

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K012459 p. 1/3

MEDTRONIC CONFIDENTIAL

Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence

AUG 1 4 2001

# ATTACHMENT D 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE

#### Submitter

Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Contact: Tina Benoit, Associate Product Regulation Manager Telephone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Prepared: July 31, 2001

# Name of Device

Trade Name: Temporary Pacemaker Electrode, 74 LDF Common Name: Temporary Pacing Lead Classification: Class II

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K012459 p.2/3

MEDTRONIC CONFIDENTIAL

Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence

#### Predicate Devices

The predicate device for the Model 6494 Unipolar Temporary Myocardial Pacing I ne products as the currently market released Model 6494 Unipolar Temporary Myocardial Pacing Wire.

#### Device Description

The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi-filament wire. One end of this wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.

### Packaging

The sterile packaging for the Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of a double pouch configuration. The inner pouch (or package liner) and outer pouch materials are transparent Tyvek - polyester/polyethylene laminate. The pouches are heat-sealed.

#### Intended Use

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The device is supplied sterile and intended for single use only.

# Technological Characteristics

The technology used with the Model 6494 Unipolar Temporary Myocardial Pacing Wire has is the same technological characteristics as the predicate device.

30

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K012459 p. 3

MEDTRONIC CONFIDENTIAL

Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence

# Summary of Studies

Medtronic, Inc. performed system compatibility testing to support that the Model 6494 Unipolar Temporary Myocardial Pacing Wire is equivalent to the predicate device. Device testing included:

- Environmental Conditioning .
- Visual Verification .
- Dimensional Testing .
- Electrical Testing .
- Mechanical Testing .

All system compatibility tests performed have demonstrated that the modified Model 6494 heartwire meets the specified requirements.

# Sterilization Validation

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is sterilized using a 100% Ethylene Oxide (EtO) sterilization process. Processes appropriate for sterilizing the devices were validated.

# Conclusion

Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. Market clearance of the Model 6494 Unipolar Temporary Myocardial Pacing Wire is supported through this Special 510(k) Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

AUG 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina L. Benoit Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K012459

Trade Name: Model 6494 Unipolar Temporary Myocardial Pacing Wire Regulation Number: 21 CFR 870.3680 Regulatory Class: Class II (two) Product Code: 74 LDF Dated: July 31, 2001 Received: August 1, 2001

Dear Ms. Benoit:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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#### Page 2 - Ms. Tina L. Benoit

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you declies specific as in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small micrifacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Douk Tith

ames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Indications for Use

# INDICATIONS FOR USE

510(k) Number (if known):

K012459

NA

Device Name:

Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire

Indications For Use:

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

DaVatell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012451

(Optional Format 1-2-96)